MAUDE Adverse Event Report: STRYKER GMBH IMPACTOR ASSEMBLY OMEGA 3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that the impactor broke.No debris were left in the patient's body.
Additional Manufacturer Narrative
Please see correction d lot code was revised.The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.By doing a visual inspection, the received impactor was found to be broken from the middle and damaged & deformed at the proximal part.The random breakage line at the middle indicates towards application of a sudden impact.The rest of the damaged part all indicated towards high impact forces being applied on the impactor.Note that this is a device where consistent high forces are being applied due to which the device has finally given up.It cannot be excluded that normal material wear also contributed to the failure over the years of usage.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.The breakage of the impactor happened due to intense hammering during use.If any further information is provided, the complaint report will be updated.
Event or Problem Description
The customer reported that the impactor broke.No debris were left in the patient's body.

• Brand Name: IMPACTOR ASSEMBLY OMEGA 3
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13031663
• Report Number: 0008031020-2021-00500
• Device Sequence Number: 19946454
• Product Code: LXH
• UDI-Device Identifier: 04546540113078
• UDI-Public: 04546540113078
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 704001
• Device Catalogue Number: 704001
• Device Lot Number: N10623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female